The following data is part of a premarket notification filed by Freedom Meditech, Inc. with the FDA for Clearpath Ds-120(r) Lens Fluorescence Biomicroscope.
| Device ID | K112880 |
| 510k Number | K112880 |
| Device Name: | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | FREEDOM MEDITECH, INC. 10455 PACIFIC CENTER COURT San Diego, CA 92121 |
| Contact | Craig H Misrach |
| Correspondent | Craig H Misrach FREEDOM MEDITECH, INC. 10455 PACIFIC CENTER COURT San Diego, CA 92121 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2013-01-31 |
| Summary: | summary |